Informed Consent

Medical profession’s deontology is aligned to human rights values through several principles that have been enforced in the twentieth century by international and national guidelines. Highly controversial research studies and shocking abuses of subjects during the WWII led to a shift from what had been until that time a paternalistic approach in medicine. Patient autonomy and research subjects’ right to be informed and to consent began to be the center of medical practice and research. Respect for persons entails that the patients have the right to act as autonomous agents and both physicians and researchers should encourage such actions. Nevertheless, informed consent issues arise in both the clinical and research settings when dealing with vulnerable populations, and with prospective research participants with different education levels, culture, and socioeconomic levels. At the core of providing legitimacy to research with human beings and making the distinction between medical intervention and battery or assault lies informed consent, a complex concept rather than a signed document.